Alamycin La 200 Mg/Ml Solution For Injection
Revised: November 2011
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the Veterinary Medicinal Product
Alamycin LA 200 mg/ml solution for injection
2. Qualitative and Quantitative Composition
Oxytetracycline Dihydrate 21.6% w/v (Equivalent to Oxytetracycline 20.0% w/v)
Sodium Formaldehyde Sulphoxylate Dihydrate (0.4%w/v)
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Solution for injection.
A clear amber solution.
4. Clinical Particulars
4.1 Target species
Cattle, sheep and pigs.
4.2 Indications for use, specifying the target species
The product is indicated for use in cattle, sheep and pigs in the treatment of:
- Atrophic rhinitis caused by Bordetella bronchiseptica, Mannheimia haemolytica and Pasteurella multocida.
- Navel/joint ill caused by Arcanobacterium pyogenes, E. coli or Staphylococcus aureus.
- Mastits caused by Corynebacterium pyogenes, E. coli, Staphylococcus aureus, Streptococcus agalactiaeor Streptococcus uberis.
- Metritis caused by E. coli or Streptococcus pyogenes.
- Pasteurellosis and infections of the respiratory tract caused by Mannheimia haemolytica and Pasteurella multocida.
- Septicaemia caused by Salmonella dublin and Streptococcus pyogenes.
- Erysipelas caused by Erysipelothrix rhusiopathiae.
The product can also be used in the control of enzootic abortion in sheep.
Not for use in horses, dogs, cats.
Not for use in animals suffering from hepatic or renal damage.
4.4 Special Warnings for Each Target Species
No special warnings.
4.5 Special Precautions for Use
i. Special Precautions for use in animals
Do not dilute the product.
If concurrent treatment is administered, use a separate injection site.
ii. Special precautions to be taken by the person administering the product to the animals
Wash hands after use. In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur.
Take care to avoid accidental injection
4.6 Adverse reactions (frequency and seriousness)
Although the product is well tolerated, occasionally a slight local reaction of a transient nature has been observed.
4.7 Use during pregnancy, lactation or lay
The use of oxytetracycline during the period of tooth and bone development, including late pregnancy may lead to tooth discoloration, the product can be safely administered to lactating animals.
4.8 Interactions with other medicinal products and other forms of interaction
4.9 Amount to be administered and administration route
The recommended dose rate is 20 mg/kg bodyweight (i.e. 1 ml per 10 kg bodyweight) administered by deep intramuscular injection. The product is recommended for a single administration only.
Maximum recommended dose at any one site:
Cattle : 20ml
Pigs : 10ml
Sheep : 5ml
Piglets: 1 day 0.2ml
7 days 0.3ml
14 days 0.4ml
21 days 0.5ml
Over 21 days 1.0 ml/10kg.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
There is no known specific antidote, if signs of possible overdose occur, treat the animal symptomatically.
4.11 Withdrawal periods
Cattle: Meat – 31 days
Milk – 10 days
Sheep: Meat – 9 days
Milk – 7 days
Pigs: Meat – 18 days
5. Pharmacological Properties
Pharmacotherapeutic group: Antibiotic
ATCvet Code: QJ01AA06
5.1 Pharmacodynamic properties
Oxytetracycline is a bacteriostatic antibiotic that inhibits protein synthesis in susceptible bacteria. Inside the cell it binds irreversibly to receptors on the 30S subunit of the bacterial ribosome where it interferes with the binding of the aminoacyl-transfer RNA to the acceptor site on the messenger RNA ribosome complex. This effectively prevents the addition of amino acids to the elongating peptide chain, inhibiting protein synthesis. The product is specifically formulated to provide a prolonged action resulting in sustained antibacterial activity.
Oxytetracycline had been shown to be effective in vitro against the following bacterial species: Bordetella bronchiseptica, Corynebacterium pyogenes, Erysipelothrix rhusiopathiae, Escherichia coli, Haemophilus somnus, Pasteurella haemolytica, Pasteurella multocida, Salmonella dublin, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes and Streptococcus uberis.
5.2 Pharmacokinetic properties
Blood levels persist for at least 4 days after administration by the intramuscular route. Maximum blood levels are achieved between 4 and 8 hours following intramuscular administration.
6. Pharmaceutical Particulars
List of excipients
Sodium formaldehyde sulphoxylate dihydrate
Magnesium Oxide Light
Disodium Edetate Dihydrate
Water for Injections
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 28 days.
6.4 Special precautions for storage
Do not store above 25ºC. Protect from light.
Following withdrawal of the first dose, use the product within 28 days.
Discard unused material
When the vial has been broached and contents exposed to air, the solution may darken but the potency will be unchanged.
6.5 Nature and composition of immediate packaging
Amber type I or II glass vials of 50 ml and 100 ml sealed with Bromobutyl Rubber Bungs and aluminium overseals.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Co. Down, BT35 6JP
8. Marketing Authorisation Number
9. Date of First Authorisation/Renewal of the Authorisation
Date: 20th October 1993/20th October 2003
10. Date of Revision of the Text
Date: November 2011
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